Phase 3
N=60
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
Bottom Line
View on ClinicalTrials.gov: NCT03255226 ↗Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Aug 2024
Primary outcome: Primary: Percentages of Subjects Whose Was Decreased by 1.7% or More Body Weight From Baseline — 22.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tolvaptan (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Subjects Whose Was Decreased by 1.7% or More Body Weight From Baseline |
22.8 | — |
| SECONDARY Change Rate From Baseline in Daily Urine Volume |
53.1; 47.8; 45.8 | — |
| SECONDARY Percent Changes From Baseline in Body Weight (kg) |
-0.371 | — |
| SECONDARY Improvement Rates of Lower Limb Edema |
68.6 | — |
| SECONDARY Improvement Rates of Pulmonary Congestion |
51.6 | — |
Summary
To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF patients with volume overload
Eligibility Criteria
Inclusion Criteria
- Patients with volume overload despite having received any of the following diuretic therapies in whom sufficient effects cannot be expected even if the dose of the diuretics is increased or in whom the investigator or subinvestigator judges that increasing the dose of the diuretics is difficult due to concerns regarding electrolyte abnormalities or other side effects
- Furosemide (oral administration) ≥0.5 mg/kg/day. Azosemide 30 mg and torasemide 4 mg will be calculated as equivalent to furosemide 20 mg.
- Hydrochlorothiazide ≥2 mg/kg/day
- Trichlormethiazide ≥0.05 mg/kg/day
- Spironolactone ≥ 1 mg/kg/day
- Patients capable of complaining of thirst. Patients unable to complain of thirst due to their young age can also be enrolled in the trial if strict management of fluid intake and excretion is conducted. However, even if such fluid management is possible, the patients in whom the investigator or subinvestigator judges that tolvaptan cannot be safely administered are to be excluded
- Patients who can be hospitalized from at least 3 days before start of tolvaptan administration until 2 days after the final administration.
others
Exclusion Criteria
- Patients whose volume overload status shows improvement during the screening period or pretreatment observation period
- Patients who are unable to drink fluid (including patients who are unable to sense thirst)
- Patients whose circulatory blood flow is suspected to be decreased
- Patients with an assisted circulation apparatus
- Patients with hypernatremia (serum or blood sodium concentration exceeding 145 mEq/L) others
Data sourced from ClinicalTrials.gov (NCT03255226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.